Du übernimmst die Leitung von Projekten im Design Quality Engineering und entwickelst Designkontrollwerkzeuge sowie Validierungspläne für neue Produkte.
Anforderungen
- •Bachelor’s Degree in Engineering or science
- •5 years hands-on experience in FDA / MDR
- •Experience in design controls and risk management
- •Knowledge of statistical methods in regulated industry
- •Experience in executing and analyzing validations
Deine Aufgaben
- •Führung im Design Quality Engineering übernehmen
- •Designkontrollwerkzeuge für globale Anwendungen entwickeln
- •Validierungs-Masterpläne und Projektpläne erstellen
- •Designanforderungen festlegen, überprüfen und genehmigen
- •Qualifikationen/Validierungen entwickeln und dokumentieren
- •Risikomanagementdokumente erstellen, überprüfen und genehmigen
- •Einhaltung von Vorschriften für globale Genehmigungen sicherstellen
- •Mit mehreren Produktionsstätten kommunizieren
Deine Vorteile
Spannendes Tätigkeitsfeld
Eigenverantwortliches Aufgabengebiet
Aktive Mitwirkung im internationalen Qualitätsteam
Intensive Schulung mit Mentorenprogramm
Vielfältige Benefits wie hybrides Arbeiten
Original Beschreibung
# Design Quality Engineer III (m/f/d)
* Hechingen
* Publiziert: 28.03.2025
We are hiring a
**Design Quality Engineer III (m/f/d)**
## Your Strength
* Minimum of a Bachelor’s Degree in an Engineering or science field, or equivalent work experience
* Minimum of 5 years hands-on experience; preferably in a FDA / MDR regulatory industry (i.e., pharmaceutical, biomedical, medical device field) with an in-depth knowledge of current Good Manufacturing Practices, Quality System Regulations, and ISO Standards
* Proven experience in design controls and risk management, from design concept to commercialization
* Good knowledge of application of statistical methods and acceptance sampling within a regulated industry such as medical device manufacturing or pharmaceutical
* Specific experience in designing, preparing, executing, and statistically analyzing validations, as well as developing report packages, to approve equipment, processes, and software
## Your Contribution
* Provide Design Quality (Design Assurance) Engineering project leadership to ensure the successful development and commercial launch of new products
* Develop design control tools for global application of harmonized design control processes
* Create Validation Master Plans and Validation Project Plans
* Establish, review, and approve design input requirements as appropriate
* Develop, conduct, and document qualifications / validations
* Develop, review and approve risk management documents, including plans, reports, and FMEAs
* Ensure that the company complies with all applicable federal, industry, and corporate procedures, guidelines, and regulations to optain global regulatory approvals
* Interface with multiple manufacturing facilities
## Our Strength
* An exciting field of activity
* An autonomous area of responsibility
* Active participation in an international Quality Team
* Intensive training with mentoring program
* Diverse benefits such as hybrid working, business bike, company pension & subsidy for our canteen